Faverin 50mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

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Active ingredient:

FLUVOXAMINE MALEATE

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

N06AB08

INN (International Name):

FLUVOXAMINE MALEATE 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FLUVOXAMINE MALEATE 50 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2007-05-16

Patient Information leaflet

                                FAVERIN
®
50 MG AND 100 MG FILM-COATED TABLETS
fluvoxamine maleate
•
FAVERIN TREATS DEPRESSION AND OBSESSIVE COMPULSIVE DISORDER (OCD).
Like all medicines it
can have unwanted effects. It is therefore important that you and your
doctor weigh up the
benefits of treatment against the possible unwanted effects, before
starting treatment.
•
FAVERIN SHOULD NOT BE USED TO TREAT DEPRESSION IN CHILDREN AND
ADOLESCENTS UNDER 18.
See
section 2, Use in Children and adolescents under 18.
•
FAVERIN WON’T WORK STRAIGHT AWAY.
Some people taking antidepressants feel worse before
feeling better. Your doctor should see you regularly during your
course of treatment. Tell your
doctor if you haven’t started feeling better.
•
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES
. If you
start to feel worse, or think of harming or killing yourself,
SEE YOUR DOCTOR OR GO TO A HOSPITAL
STRAIGHT AWAY.
•
DON’T STOP TAKING FAVERIN WITHOUT TALKING TO YOUR DOCTOR.
If you stop taking Faverin
suddenly or miss a dose, you may get withdrawal effects. See Section
3, How to take Faverin.
•
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
TELL YOUR DOCTOR.
Increasing the
dose of Faverin may make these feelings worse.
•
TAKING SOME OTHER MEDICINES WITH FAVERIN CAN CAUSE PROBLEMS.
You may need to talk to
your doctor. See section 2, Are you taking any other medicines.
•
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT
, talk to your doctor. See section 2,
Pregnancy and breastfeeding.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT FAVERIN IS AND WH
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Faverin 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg fluvoxamine maleate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, biconvex, scored, white to off-white film coated tablets
imprinted '291' on both
sides of the score.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Major depressive episode
-
Obsessive Compulsive Disorder (OCD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Depression _
_Adults _
The recommended dose is 100 mg daily. Patients should start on 50 or
100 mg, given
as a single dose in the evening. Dosage should be reviewed and
adjusted if necessary
within 3 to 4 weeks of initiation of therapy and thereafter as judged
clinically
appropriate. Although there may be an increased potential for
undesirable effects at
higher doses, if after some weeks on the recommended dose insufficient
response is
seen some patients may benefit from having their dose increased
gradually up to a
maximum of 300 mg a day (see section 5.1). Doses up to 150 mg can be
given as a
single dose, preferably in the evening. It is advisable that a total
daily dose of more
than 150 mg is given in 2 or 3 divided doses. Dosage adjustments
should be made
carefully on an individual patient basis, to maintain the patients at
the lowest effective
dose.
Patients with depression should be treated for a sufficient period of
at least 6 months
to ensure that they are free from symptoms.
_Children/adolescents _
Faverin should not be used in children and adolescents under the age
of 18 years for the
treatment of major depressive episode. The efficacy and safety of
Faverin have not been
established in the treatment of paediatric major depressive episode
(see section 4.4).
_Obsessive Compulsive Disorder _
_Adults _
The recommended dose is between 100-300 mg daily. Patients should
start at 50 mg
per day. Although there may be an inc
                                
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